Kornimate/medical-research-clean huggingface dataset:
the allurion digital behaviour change intervention

Conditions: Obesity

Summary: the proposed study is a prospective, non-randomized, pilot study to test the impact of the allurion digital behaviour change intervention (dbci) in participants who have been treated with the allurion™ gastric balloon system. the study will include a nested qualitative and quantitative evaluations of the intervention from both the participant and allurion provider perspective.

the study consists of the following: * screening and enrolment period (prior to or day of allurion gastric balloon system treatment) * all participants will take part in the allurion dbci for 6 months following study enrolment * all participants will complete a 6-month follow-up assessment after completion of the allurion dbci

Eligibility criteria:
inclusion criteria: * allurion gastric balloon system placement in accordance with the approved indications for use * age 18 to 65 years of age * bmi ≥ 27 * weight \< 180 kg * owns an android or apple smart phone * willing to download the allurion app * willing to wear the allurion health tracker watch for the duration of the study * willing to use the allurion scale * proficient in reading the english language exclusion criteria: - any condition contraindicated for the allurion gastric balloon system as specified in the instructions for use

Keywords: intragastric balloon
palliative care and quality of life in idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis; Depression; Anxiety; Depressive Disorder; Anxiety Disorders; Anxiety Depression

Summary: the purpose of this study is to evaluate the effects of adding a palliative care intervention for patients with idiopathic pulmonary fibrosis (ipf) to current standard of care. palliative care is comprehensive, coordinated interdisciplinary care for patients and families facing a potentially life-threatening illness. this consists of specially trained teams of professionals including physicians, nurses, social workers, and chaplains that provide care and support in inpatient and outpatient settings. while the specific assistance and support provided by the palliative care service depends on individual patient and family needs and preferences, it may include: 1. pain and symptom management 2. psychosocial and spiritual support 3. assistance with treatment choices 4. help in planning for care in the community

idiopathic pulmonary fibrosis (ipf) is a progressive and heterogeneous fibrotic lung disease. it is universally fatal, with an average time to death between two to five years. patients with ipf experience significantly diminished quality of life and increased symptom burden. besides dyspnea, cough, fatigue, and deconditioning, patients with ipf experience significant depression and anxiety. the benefit of palliative care has been demonstrated in several other diseases, notably, in metastatic lung cancer. patients with metastatic lung cancer who were seen by palliative care at the time of their diagnosis and throughout their disease course were found to have increased survival, improved quality of life, and received less aggressive care at the end of their life. this finding has prompted significant research in the role of palliative care in other diseases, including chronic lung disease. a non-blinded, randomized trial of a multi-disciplinary breathlessness service intervention in patients with advanced disease including cancer, chronic obstructive lung disease (copd), interstitial lung disease (ild), and congestive heart failure demonstrated improvement in breathlessness, anxiety, and even survival. specific aim 1: determine if quality of life is improved with a palliative care intervention. specific aim 2: determine if depression and anxiety symptoms are decreased with a palliative care intervention. secondary aims include an examination of pulmonary function tests (pft), number of hospitalizations, and overall mortality as an effect of a palliative care intervention.

Eligibility criteria:
inclusion criteria: * ipf as diagnosed by chest ct or lung biopsy, and documented by a pulmonologist in the patient's medical record * capacity to provide informed consent exclusion criteria: * documented malignancy that would impact mortality within the study enrollment period * inability to pay for palliative care visit, insurance or personally.

Keywords: palliative care
ozone application in periodontal treatment

Conditions: Periodontitis

Summary: this clinical trial aims to evaluate the clinical, biochemical and microbiological efficacy of ozone treatment as an adjunct to nonsurgical periodontal treatment (nspt) in periodontitis patients. the main question it aims to answer is: • is the application of gaseous ozone, as an adjunct to nspt, to periodontal pockets in patients with periodontitis alters the clinical periodontal parameters, gingival crevicular fluid levels of inflammatory cytokines, and periodontal pathogens compared to nspt alone? the study will be performed according to a split-mouth design, the contralateral quadrants with similar periodontal status in each patient will be randomly allocated to one of the following two different treatment modalities. participants will be applied nspt consisting of supra and subgingival debridement. * nspt will be applied alone in one quadrant * in addition to nspt, ozone therapy procedures were performed using a device at contralateral sites. researchers will compare the sites with and without ozone therapy in addition to nspt to see if ozone therapy adjunct to the nspt affects clinical, biochemical, and microbiological changes


Eligibility criteria:
inclusion criteria: * systemically healthy * no periodontal treatment within 6 months from the enrollment date * no antibiotics or anti-inflammatory medication taken within 6 months from the enrollment date * no smokers * no pregnancy or lactation at the time of the stud * no contraindication for periodontal treatment and ozone application exclusion criteria: * participants will be excluded if they had less than 20 teeth, partial dentures, or fixed prosthodontics.

Keywords: periodontitis ozone treatment
collagenase chemonucleolysis vs percutaneous endoscopic lumbar discectomy (peld) for lumbar disc herniation

Conditions: Lumbar Disc Herniation

Summary: lumbar disc herniation compressed the nerve cause pain, numbness, weak legs called sciatica, which seriously decrease the quality of life and work efficiency. both collagenase chemonucleolysis(ccnl) and percutaneous endoscopic lumbar discectomy (peld) was effective to treat lumbar disc herniation(ldh) requires surgery. whether functional clinical outcomes of ccnl vs peld effect on ldh was superior, and no study provided convincing evidence.

lumbar disc herniation (ldh) is a common disease with an incidence of 1%-3%, usually manifested as low back pain radiating to the lower extremities, which seriously affects patients' quality of life. collagen hydrolysis was effective in treating ldh, it makes the protrusion smaller or disappeared, relieving or resolving the compression of nerve root by the protrusion.percutaneous endoscopic lumbar discectomy (peld) is a less invasive techniques to treat ldh. however, the outcomes of collagen hydrolysis vs peld effect was still unknown.

Eligibility criteria:
inclusion criteria: * at least six weeks of excessive radiating leg pain with no tendency for any clinical improvement despite conservative therapy * have a nerve root compression by a lumbar disc herniation proven by magnetic resonance imaging exclusion criteria: * previous surgery at the same or adjacent disc level; * isthmic or degenerative spondylolisthesis * pregnancy * severe comorbid medical or psychiatric disorder (american society of anesthesiologists' classification \>2); * severe caudal or cranial sequestration of disc fragments, defined as sequestration towards more than half of the adjacent vertebra; * contraindication for surgery
automated analysis of eit data for peep setting

Conditions: Acute Hypoxemic Respiratory Failure; Post-cardiac Surgery

Summary: first: to develop a computerized algorithm for automated analysis of the electrical impedance tomography (eit) data. the algorithm calculates the "optimal" positive end-expiratory pressure (peep) and inspiratory pressure defined as the "optimal" balance between stretch, ventilation distribution and collapse. second: to compare the results of the algorithm with the current standard of care clinical judgement of an experienced ventilation practitioner.

the study will be performed at the intensive care unit, maastricht university medical centre. the investigators routinely apply eit (pulmovista, dräger, lübeck. germany) in mechanically ventilated patients to optimize the ventilator settings . an algorithm will be developed by the institute of technical medicine, furtwangen university, germany. the algorithm will automatically detect changes in both peep and inspiratory pressures. for each peep step and/or changes in inspiratory pressure the difference in regional alveolar overdistension and alveolar collapse will be calculated. this makes it possible to select the optimal ventilator setting depending on the best compromise between alveolar overdistension and alveolar collapse. the algorithm will be tested in 40 eit guided mechanically ventilated patients. eit measurements will be performed during an incremental and decremental peep trial. the eit measurement will be performed in the same way as during standard clinical care. eit data will be analysed offline by a ventilation practitioner with experience in eit and with the newly developed algorithm. the resulting advice on optimal ventilator settings will be compared for inter-observer variability.

Eligibility criteria:
inclusion criteria: * mechanically ventilated in a volume or pressure controlled mode * ventilator settings guided by eit exclusion criteria: * participants who specifically opt-out regarding the use of the data for research purpose * internal pacemaker, implantable cardioverter defibrillator * skin lesions, dressings at the thorax, hindering belt placement * thoracic circumference \< 70 cm * thoracic circumference \> 150 cm * bmi \> 50

Keywords: peep electrical impedance tomography
a phase i/ii safety, tolerability, immunogenicity, and bioactivity study of de-122 injectable solution for refractory exudative age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: the purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (ivt) administration of de-122 in subjects with refractory exudative age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * provide signed written informed consent * diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration * prior treatment in the study eye with any intravitreal anti-vegf medication * at least one lesion in the study eye that meets minimal pathology criteria * best corrected visual acuity of 65 to 20 etdrs letters in the study eye * best corrected visual acuity of 20/200 or better in the fellow eye * reasonably clear media and some fixation in the study eye exclusion criteria: ocular * use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of amd within a specified timeframe prior to visit 1 * uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye * evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study * need for ocular surgery in the study eye during the course of the study * presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform required study assessments in either eye and/or confound study results non-ocular * allergy or hypersensitivity to study drug product, fluorescein dye or other study-related procedures and medications * current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study * participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study * females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study * unable to comply with study procedures or follow-up visits

Keywords: macular degeneration
an observational study of cpt-11 based regimens and ugt1a1 genotypes in metastatic colorectal cancer (mcrc)

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to examine the correlation between ugt1a1 genotypes and the efficacy of cpt-11 based regimens (folfiri, cpt-11+s-1, cpt-11) for patients with metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer (adenocarcinoma) * ugt1a1 genotyped patients * patients to receiving folfiri, cpt-11+s-1 and cpt-11 alone therapy (with or without molecular targeted agents) exclusion criteria: * contraindication of cpt-11 * eastern cooperative oncology group (ecog) performance score (ps) 3-4 * patients to receiving cpt-11 as adjuvant chemotherapy * history of pelvic irradiation

Keywords: ugt1a1, irinotecan
pain reduction after cholecystectomy

Conditions: Cholecystolithiasis; Postoperative Pain

Summary: to determine the effect of combined intracutaneous infiltration and intraperitoneal instillation of 80 ml 0,125% levobupivacaine prior to the start of laparoscopic cholecystectomy on abdominal pain up to 24 hours after surgery.

the primary endpoint of this study was postoperative abdominal pain as measured by a visual analogue scale (vas), using a vas lineal with a slide. the patient was asked to indicate a score from 0 to 100 corresponding to his or her pain. at 0.5, 2, 4, 8 and 24 hours after the surgical procedure the primary investigator visited the patient to obtain the vas scores.

Eligibility criteria:
inclusion criteria: * between 18 and 80 * asa i or ii * with symptomatic gallstone disease which requires elective laparoscopic cholecystectomy exclusion criteria: * acute cholecystitis, cholangitis, severe acute pancreatitis, advanced liver cirrhosis or suspected gallbladder cancer, * a medical history of epilepsy, cardiac arrhythmias or chronic pain of any kind, - allergy to amid type drugs * pregnancy * patients suffering from hypotension or hypovolemia * infectious liver disease * conditions obstructing adequate pain scoring * patients using drugs that deduce function of the cyp3a4 or cyp1a2 system * patients having an american society of anaesthesiologists (asa) classification of three or higher.

Keywords: gallstone gallbladder cholecystectomy laparoscopic pain
high dose chemotherapy using beeam for autologous transplant in multiple myeloma

Conditions: Multiple Myeloma

Summary: high-dose chemotherapy and autologous stem cell transplantation (asct) as part of the up-front treatment of patients with multiple myeloma has been associated with improved disease-free and overall survival in multiple large randomized controlled trials. following 3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose melphalan and asct has become the standard-of-care approach for fit myeloma patients up to 70 years of age. single-agent high-dose melphalan (200mg/m2) is currently the standard-of-care preparative regimen prior to autologous transplant in myeloma. historical studies utilizing busulfan- or total body irradiation-based preparative regimens have yielded similar results to single-agent melphalan with higher toxicity.

myeloma patients, following up-front induction therapy, will receive an asct following a high-dose bendamustine-based preparative regimen (beeam). the primary endpoint of this trial will be the rate of cr at day 100 post-transplant. experience from the literature, as well as results from our institution, suggests that following asct for the upfront treatment of myeloma, the rate of cr at day 100 post-transplant is approximately 45%. it is hoped that under this protocol, this rate will be at least 65%. thus we statistically formalize this study by testing the null hypothesis that p, the cr rate is 0.65 or more versus the alternative hypothesis that p is less than 0.45. a sample size of 65 pts gives 90% power with an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.

Eligibility criteria:
inclusion criteria: * age between 18 - 70 years * karnofsky status ≥ 70% * diagnosis of multiple myeloma * within 9 months of the start of induction chemotherapy and no evidence of relapse or progression. * availability of cryopreserved peripheral blood stem cells with a cd34 dose of at least 2x106/kg. exclusion criteria: * poor cardiac function: left ventricular ejection fraction \<40% * poor pulmonary function: fev1, fvc, or dlco \<40% predicted * poor liver function: bilirubin \>2.5 mg/dl (not due to hemolysis, gilbert's or primary malignancy), ast/alt \> 3x uln * poor renal function: creatinine \>2.0 mg/dl or creatinine clearance \< 40 ml/min (calculated creatinine clearance is permitted) * ongoing or active systemic infection, active hepatitis b or c virus infection, or known human immunodeficiency virus (hiv) positive. * women of childbearing potential who currently are pregnant or who are not practicing adequate contraception * patients who have any debilitating medical or psychiatric illness which would preclude their giving informed consent or their receiving optimal treatment and follow-up.

Keywords: multiple myeloma hematopoietic stem cell transplant
suvorexant in insomnia co-morbid with fibromyalgia

Conditions: Insomnia; Fibromyalgia

Summary: this study will compare sleep, pain and daytime sleepiness/fatigue in people with insomnia co-morbid with fibromyalgia while treated short-term with suvorexant 20 mg versus placebo.

it has now become clear that the relation of sleep and pain is bidirectional; acute and chronic pain is associated with disturbed sleep and disturbed sleep enhances pain. experimental studies have shown that reduced and fragmented sleep in pain-free normals increases their pain sensitivity and daily self-report studies in chronic pain patients have shown a poor night of sleep is followed by enhanced next-day pain. in mediation analyses of large clinical data sets it is found that the sleep-pain side of the bidirectional relation, as opposed to the pain-sleep side, accounts for the greater variance. these data then would suggest that improving sleep in chronic pain disorders should attenuate daytime pain. most of the drugs used to treat chronic pain facilitate inhibitory central nervous system mechanisms as their primary mechanism of action. suvorexant, recently approved by the fda for the treatment of insomnia characterized by difficulties with sleep onset and sleep maintenance, has a unique mechanism of action. suvorexant is a selective antagonist for orexin receptors (ox1r and ox2r). orexins are considered to be involved in arousal and maintenance of the waking state. as such, suvorexant may provide unique clinical benefit as a treatment in chronic pain conditions with co-morbid insomnia, and specifically for fibromyalgia with its putative central hyperarousal and hypersensitization. thus, this project proposes to study objective and clinical measures of sleep, pain, and daytime sleepiness and fatigue in patients with fibromyalgia and co-morbid insomnia while treated short-term with suvorexant 20 mg versus placebo. those qualifying will receive suvorexant 20 mg and placebo for each of 9 nights in a cross over design with 7 nights of washout between treatments. overnight sleep recordings (psgs) will be collected on nights 7 and 8 of each crossover treatment arm to determine objective sleep measures. during the day following night 7 in each arm, a multiple sleep latency test (mslt) at 1000, 1200, 1400, and 1600 hr will be conducted and nociceptive sensitivity \[finger withdrawal latency (fwl)\] testing to a radiant heat stimulus (1100 and 1500 hr) will be conducted on day 1 and day 8. self-reported mood and pain indices will also be completed prior to each fwl test. primary outcomes to be measured include psg sleep efficacy and fwl response on both conditions (suvorexant 20 mg versus placebo).

Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual 5th ed criteria for insomnia * meet american college of rheumatology criteria for fibromyalgia * otherwise good psychiatric and stable physical health exclusion criteria: * other primary sleep disorders * pain symptoms unrelated to fibromyalgia * current pregnancy or breast-feeding

Keywords: insomnia fibromyalgia polysomnography pain management
development of workshop for lifestyle changing for crohn's disease patients and its affect on the disease's indexes

Conditions: Crohn's Disease

Summary: subjects that participate in the practical workshop will improve their quality of life and will stay longer in remmision , in compare to the participants that will continue their regular threatment

participants will be randomly assigned to a regular threatment (control group) or to a lifestyle changing workshop. the workshop will consist of 11 meetings with behavioral lessons in nutrition, cooking, stress realese and physical activity. the study population will include 100 crohn's disease patients in remmision that will be recruited and will be randomly divided into two groups: an intervention group of 50 will commence the workshop during 2007 and a control group of 50 who will continue their regular threatment. an ibdq , cdai and blood samples for metabolic index will be taken from the participant in the staudy before entering the study and every half a year for three years.

Eligibility criteria:
inclusion criteria: * over 18 years of age * diagnosed with cd * crohn's disease activity index (cdai) of under 170 * a minimum of 75% of the meetings exclusion criteria: * patients with a stoma * and patients with a planned admission to the hospital for surgery or other treatment.

Keywords: crohns quality of life lifestyle changing remmision